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Forehead Scars Following Mohs Micrographic Surgery and Reconstruction for Skin Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2012 by AboutSkin Dermatology, AboutSkin Dermatology and DermSurgery, PC.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01459666
First Posted: October 26, 2011
Last Update Posted: January 18, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University Hospitals Cleveland Medical Center
Medicis Pharmaceutical Corporation
Information provided by (Responsible Party):
AboutSkin Dermatology, AboutSkin Dermatology and DermSurgery, PC
October 18, 2011
October 26, 2011
January 18, 2012
September 2011
December 2012   (Final data collection date for primary outcome measure)
Patient and Observer Assessment Scale (POSAS) [ Time Frame: 6 months ]
The Patient and Observer Scar Assessment Scale (POSAS) consists of two numeric scales. One scale is completed by the patients, the other by the clinician. This scale is different than previous scales because it takes the patient's input into consideration. It has good internal consistency and interobserver reliability. The assessment will take place at Day 0, Week 1, Week 6, and Month 6.
Same as current
Complete list of historical versions of study NCT01459666 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Forehead Scars Following Mohs Micrographic Surgery and Reconstruction for Skin Cancer
A Prospective, Dual-center, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy of abobotulinumtoxinA (BTX-A) in Improving Forehead Wounds After Mohs Micrographic Surgery and Reconstruction for Skin Cancer
Evaluate the efficacy and safety of using aboBTX-A to improve wound healing prior to Mohs micrographic surgery and reconstruction for skin cancer of the forehead
  • Outcomes by the Patient and Observer Assessment Scale (POSAS), Visual Analog Scale, and Patient Satisfaction Survey.
  • Study consists of 5 clinic visits over approximately 6 months
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Scar
  • Drug: Dysport (abobotulinumtoxinA)
    Intramuscular injection effects lasting up to 3 months
  • Drug: Bacteriostatic 0.9% Sodium Chloride (vehicle)
    Intramuscular injection
  • Experimental: Dysport (abobotulinumtoxinA)
    Intervention: Drug: Dysport (abobotulinumtoxinA)
  • Placebo Comparator: Placebo
    Intervention: Drug: Bacteriostatic 0.9% Sodium Chloride (vehicle)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
50
June 2013
December 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Have biopsy proven skin cancer on the forehead that is amenable to Mohs surgery
  • Undergoing elective reconstruction of biopsy proven skin cancer that is amenable to Mohs surgery with defect size measuring 1.0 cm or greater
  • If female, not currently pregnant, not currently breastfeeding, no potential for pregnancy, or if of child-bearing age, agrees to using birth control.
  • Agrees to not use disallowed concomitant medications (retinoids) and agrees to use sunscreen in the forehead area for the duration of the study

Exclusion Criteria:

  • Current or past history of a neuromuscular disease (such as myasthenia gravis, amyotrophic lateral sclerosis, Eaton-Lambert syndrome)
  • History of radiation therapy or chemotherapy
  • History of keloid or other hypertrophic scar formation
  • Has used botulinum toxin in the forehead area within one year.
  • Has used any topical retinoids to the forehead area within the past 4 weeks
  • Any hypersensitivity to any component of abobotulinumtoxinA (i.e. cow milk protein) or any previous hypersensitivity to any botulinum toxin A or related product.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01459666
Mann-Cohen Version 2
Yes
Not Provided
Not Provided
AboutSkin Dermatology, AboutSkin Dermatology and DermSurgery, PC
AboutSkin Dermatology and DermSurgery, PC
  • University Hospitals Cleveland Medical Center
  • Medicis Pharmaceutical Corporation
Principal Investigator: Margaret Mann, MD University Hospitals Cleveland Medical Center
Principal Investigator: Joel L Cohen, MD About Skin Dermatology and Dermsurgery
AboutSkin Dermatology and DermSurgery, PC
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP